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Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

ConditionsLumbar Spinal StenosisSpinal StenosisSpinal Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorSklifosovsky Institute of Emergency Care

About this trial

Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups.

This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age of patients from 45 to 75 years;

stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;

clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and/or radiculopathy);

lack of effect from conservative therapy within 3 months;

Disqualifiers

spondylolisthesis more than 3 mm;

spinal instability according to functional radiography;

sagittal imbalance (type 4 according to C. Barrey);

bone density of the vertebrae at the level of the operation is less than 100 HU;

Trial design

Design model

Parallel

Treatments tested in this trial

  • decompression

    Procedure/Surgery

    laminotomy of the corresponding adjacent vertebrae, partial flavectomy and medial facetectomy are planned to be performed unilaterally. Depending on the surgeon's personal preferences, the following two options are available: 1) equivalent decompression procedure contralaterally and 2) crossover contralateral decompression. Irrespective of the selected option, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch must be preserved intact in all participants.

  • fusion

    Procedure/Surgery

    First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: decompression groupOther 1 intervention
Group B: fusion groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Oswestry Disability Index

The questionnaire includes 10 sections containing 6 statements each. Depending on the answer, a score is assigned (from 0 to 5). The maximum number of points is 50. After that, the points are converted into percentages (from 0 to 100%).

Time frame
24 months

Secondary outcomes

1

SF-36 v.1 scale (standard form)

The questionnaire contains 36 questions, grouped into 8 scales that assess physical functioning, role-playing, bodily pain, general health, vitality, social functioning, emotional state, and mental health. For each of them, the maximum score is 100 points.

Time frame
24 months
2

EQ-5D-5L

The questionnaire contains 5 sections (mobility, self-care, usual activities, pain, anxiety) of three statements and the EQ-VAS visual analog pain scale. The results can be converted into a single numerical value (index) adjusted for the patient's region of residence

Time frame
24 months
3

Won-Korff Chronic Pain Syndrome Assessment Scale

allows evaluating the severity of pain and its impact on life in points. Grade 0 corresponds to the absence of pain, and grade IV to the maximum limitation of life because of severe pain.

Time frame
24 months
4

Pain Catastrophizing Scale

makes it possible to assess completely the psychological aspects of pain perception, in particular the exaggerated negative perception of painful stimuli. The questionnaire contains 13 questions, each of which is evaluated in points (0 points, no symptom, 4, the patient experiences these feelings all the time).

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sklifosovsky Institute of Emergency Care

Lead sponsor

Pirogov National Medical Surgical Center

Collaborator

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

Collaborator

Source ClinicalTrials.gov
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